Pneumostoma management system packaging and kits

ABSTRACT

A flexible pneumostoma management device maintains the patency of a pneumostoma while controlling the flow of material through the pneumostoma. The device is provided to patients in a sterile tray. The tray is efficiently packaged in order to supply a patient&#39;s needs for a period of time. Auxiliary and/or diagnostic materials can also be provided as part of the kit.

CLAIM TO PRIORITY

This application claims priority the following applications:

U.S. Provisional Patent Application No. 61/408,852, filed Nov. 1, 2010,entitled “PNEUMOSTOMA MANAGEMENT SYSTEM PACKAGING AND KITS” (AttorneyDocket No. LUNG1-06024US0).

The afore-mentioned application is incorporated herein by reference inits entirety.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is related to all of the following applications, andall the patent applications that claim priority thereto, including:

U.S. patent application Ser. No. 12/388,447, filed Feb. 18, 2009,entitled “PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS FOR TREATMENT OFCHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No.LUNG1-06001US1); and

U.S. patent application Ser. No. 12/388,451, filed Feb. 18, 2009,entitled “PNEUMOSTOMA MANAGEMENT METHOD FOR TREATMENT OF CHRONICOBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No. LUNG1-06001US2); and

U.S. patent application Ser. No. 12/388,458, filed Feb. 18, 2009,entitled “FLEXIBLE PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS FORTREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No.LUNG1-06004US1); and

U.S. patent application Ser. No. 12/684,699, filed Jan. 8, 2010,entitled “PNEUMOSTOMA MANAGEMENT DEVICE WITH INTEGRATED PATENCY SENSORAND METHOD” (Attorney Docket No. LUNG1-06016US1); and

U.S. patent application Ser. No. 12/388,466, filed Feb. 18, 2009,entitled “ONE-PIECE PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS FORTREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No.LUNG1-06017US1); and

U.S. patent application Ser. No. 12/388,467, filed Feb. 18, 2009,entitled “PNEUMOSTOMA MANAGEMENT SYSTEM WITH SECRETION MANAGEMENTFEATURES FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE”(Attorney Docket No. LUNG1-06019US1); and

U.S. patent application Ser. No. 12/388,468, filed Feb. 18, 2009,entitled “MULTI-LAYER PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS FORTREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No.LUNG1-06022US1); and

U.S. patent application Ser. No. 12/388,469, filed Feb. 18, 2009,entitled “VARIABLE LENGTH PNEUMOSTOMA MANAGEMENT SYSTEM FOR TREATMENT OFCHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No.LUNG1-06023US1); and

U.S. patent application Ser. No. 13/213,945, filed Aug. 19, 2011,entitled “PNEUMOSTOMA MANAGEMENT SYSTEM PACKAGING AND KITS”, (AttorneyDocket No. LUNG1-06024US1).

All of the afore-mentioned applications are incorporated herein byreference in their entireties. This patent application also incorporatesby reference in their entireties all patents, applications, and articlesdiscussed and/or cited herein.

BACKGROUND OF THE INVENTION

In the United States alone, approximately 14 million people suffer fromsome form of Chronic Obstructive Pulmonary Disease (COPD). However, anadditional ten million adults have evidence of impaired lung functionindicating that COPD may be significantly underdiagnosed. The cost ofCOPD to the nation in 2002 was estimated to be $32.1 billion. Medicareexpenses for COPD beneficiaries were nearly 2.5 times that of theexpenditures for all other patients. Direct medical services accountedfor $18.0 billion, and indirect cost of morbidity and prematuremortality was $14.1 billion. COPD is the fourth leading cause of deathin the U.S. and is projected to be the third leading cause of death forboth males and females by the year 2020.

Chronic Obstructive Pulmonary Disease (COPD) is a progressive disease ofthe airways that is characterized by a gradual loss of lung function. Inthe United States, the term COPD includes chronic bronchitis, chronicobstructive bronchitis, and emphysema, or combinations of theseconditions. In emphysema the alveoli walls of the lung tissue areprogressively weakened and lose their elastic recoil. The breakdown oflung tissue causes progressive loss of elastic recoil and the loss ofradial support of the airways which traps residual air in the lung. Thisincreases the work of exhaling and leads to hyperinflation of the lung.When the lungs become hyperinflated, forced expiration cannot reduce theresidual volume of the lungs because the force exerted to empty thelungs collapses the small airways and blocks air from being exhaled. Asthe disease progresses, the inspiratory capacity and air exchangesurface area of the lungs is reduced until air exchange becomesseriously impaired and the individual can only take short shallowlabored breaths (dyspnea).

The symptoms of COPD can range from the chronic cough and sputumproduction of chronic bronchitis to the severe disabling shortness ofbreath of emphysema. In some individuals, chronic cough and sputumproduction are the first signs that they are at risk for developing theairflow obstruction and shortness of breath characteristic of COPD. Withcontinued exposure to cigarettes or noxious particles, the diseaseprogresses and individuals with COPD increasingly lose their ability tobreathe. Acute infections or certain weather conditions may temporarilyworsen symptoms (exacerbations), occasionally where hospitalization maybe required. In others, shortness of breath may be the first indicationof the disease. The diagnosis of COPD is confirmed by the presence ofairway obstruction on testing with spirometry. Ultimately, severeemphysema may lead to severe dyspnea, severe limitation of dailyactivities, illness and death.

There is no cure for COPD or pulmonary emphysema, only varioustreatments, for ameliorating the symptoms. The goal of currenttreatments is to help people live with the disease more comfortably andto prevent the progression of the disease. The current options include:self-care (e.g., quitting smoking), medications (such as bronchodilatorswhich do not address emphysema physiology), long-term oxygen therapy,and surgery (lung transplantation and lung volume reduction surgery).Lung Volume Reduction Surgery (LVRS) is an invasive procedure primarilyfor patients who have a localized (heterogeneous) version of emphysema;in which, the most diseased area of the lung is surgically removed toallow the remaining tissue to work more efficiently. Patients withdiffuse emphysema cannot be treated with LVRS, and typically only havelung transplantation as an end-stage option. However, many patients arenot candidates for such a taxing procedure.

A number of less-invasive surgical methods have been proposed forameliorating the symptoms of COPD. In one approach new windows areopened inside the lung to allow air to more easily escape from thediseased tissue into the natural airways. These windows are kept openwith permanently implanted stents. Other approaches attempt to seal offand shrink portions of the hyperinflated lung using chemical treatmentsand/or implantable plugs. However, these proposals remain significantlyinvasive and are still unproven. None of the surgical approaches totreatment of COPD has been widely adopted. Therefore, a large unmet needremains for a medical procedure that can sufficiently alleviate thedebilitating effects of COPD and emphysema.

SUMMARY OF THE INVENTION

In view of the disadvantages of the state of the art, Applicants havedeveloped a method for treating COPD in which an artificial passagewayis made through the chest wall into the lung. An anastomosis is formedbetween the artificial passageway and the lung by creating a pleurodesisbetween the visceral and parietal membranes surrounding the passagewayas it enters the lung. The pleurodesis prevents air from entering thepleural cavity and causing a pneumothorax (deflation of the lung due toair pressure in the pleural cavity). The pleurodesis is stabilized by afibrotic healing response between the membranes. The artificialpassageway through the chest wall also becomes epithelialized. Theresult is a stable artificial aperture through the chest wall whichcommunicates with the parenchymal tissue of the lung.

The aperture into the lung through the chest wall is referred to hereinas a pneumostoma. A pneumostoma provides an extra pathway that allowsair to exit the lung while bypassing the natural airways which have beenimpaired by COPD and emphysema. By providing this ventilation bypass,the pneumostoma allows the stale air trapped in the lung to escape fromthe lung thereby shrinking the lung (reducing hyperinflation). Byshrinking the lung, the ventilation bypass reduces breathing effort(reducing dyspnea), allows more fresh air to be drawn in through thenatural airways and increases the effectiveness of all of the tissues ofthe lung for gas exchange. Increasing the effectiveness of gas exchangeallows for increased absorption of oxygen into the bloodstream and alsoincreased removal of carbon dioxide. Reducing the amount of carbondioxide retained in the lung reduces hypercapnia which also reducesdyspnea. The pneumostoma thereby achieves the advantages of lung volumereduction surgery without surgically removing a portion of the lung orsealing off a portion of the lung.

Procedures, techniques and tools for creating a pneumostoma aredescribed in Applicants' copending patent application Ser. No.12/388,453 entitled “Surgical Instruments For Creating A Pneumostoma AndTreating Chronic Obstructive Pulmonary Disease” to Tanaka et al.Pneumostoma management devices which can be inserted into a pneumostomaand through which gases may exit a lung of a patient are described inApplicant's copending patent application Ser. No. 12/388,468 entitled“Multi-Layer Pneumostoma Management System And Methods For Treatment OfChronic Obstructive Pulmonary Disease” to Tanaka et al. These patentapplications, and all other patents and patent applications referred toherein, are incorporated by reference in their entirety.

Pneumostoma management devices and auxiliary supplies are supplied topatients on a regular basis for maintaining the pneumostoma. In somecases, pneumostoma management devices are single use disposable itemswhich are replaced daily. It is therefore desirable to provide thepneumostoma management devices to suppliers and patients in a volumeefficient manner.

In accordance with one embodiment, the present invention providessterile trays for delivery of pneumostoma management devices.

In accordance with another embodiment, the present invention provides apneumostoma management device in a sterile tray.

In accordance with another embodiment, the present invention providesvolume-efficient packaging. The packaging is configured for delivery ofa plurality of pneumostoma management devices.

In accordance with one embodiment, the present invention provides kitshaving a plurality of pneumostoma management devices secured involume-efficient packaging for delivery to a patient.

In accordance with one embodiment, the present invention provides kitshaving a plurality of pneumostoma management devices secured involume-efficient packaging and also includes one or more auxiliarysupplies used by a patient during exchange of pneumostoma managementdevices.

In accordance with one embodiment, the present invention provides kitshaving a plurality of pneumostoma management devices secured involume-efficient packaging and also includes one or moreenhanced-functionality pneumostoma management devices.

In accordance with one embodiment, the present invention provides kitshaving a plurality of pneumostoma management devices secured involume-efficient packaging for delivery to a patient and also includesfeatures to guide the patient in periodic maintenance and or assessmentof the pneumostoma

In accordance with one embodiment, the present invention provides kitshaving a plurality of pneumostoma management devices secured involume-efficient packaging for delivery to a patient. Thevolume-efficient packaging is also useful for controlled disposal ofpneumostoma management devices.

Thus, various systems, components and methods are provided for deliveryof pneumostoma management devices and managing a pneumostoma and therebytreating COPD. Other objects, features and advantages of the inventionwill be apparent from drawings and detailed description to follow.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and further features, advantages and benefits of the presentinvention will be apparent upon consideration of the present descriptiontaken in conjunction with the accompanying drawings.

FIG. 1A shows the chest of a patient indicating alternative locationsfor a pneumostoma that may be managed using the device and methods ofthe present invention.

FIG. 1B shows a sectional view of the chest illustrating therelationship between the pneumostoma, lung and natural airways.

FIG. 1C shows a detailed sectional view of a pneumostoma.

FIG. 2A shows an exploded view of components of a pneumostoma managementdevice.

FIG. 2B shows an assembled pneumostoma management device according to anembodiment of the present invention.

FIG. 2C shows a perspective view of a component of the pneumostomamanagement device of FIGS. 2A-2B.

FIG. 2D shows a perspective view of the assembled pneumostoma managementdevice of FIGS. 2A-2B.

FIG. 2E shows a sectional view of the pneumostoma management device ofFIGS. 2A, 2B, 2D inserted into a pneumostoma.

FIG. 3A shows components of covers for the adhesive portions of thepneumostoma management device of FIGS. 2A-2D.

FIG. 3B shows a component of the covers of FIG. 3A.

FIG. 3C shows a partially-covered pneumostoma management device.

FIG. 3D shows a partially-covered pneumostoma management device.

FIG. 3E shows a fully-covered pneumostoma management device according toan embodiment of the present invention.

FIG. 3F shows a perspective view of an alternate fully-coveredpneumostoma management device according to an embodiment of the presentinvention.

FIG. 4A shows an exploded view of a tray for a pneumostoma managementdevice according to an embodiment of the present invention.

FIG. 4B shows a perspective view of the tray of FIG. 4A, assembled witha pneumostoma management device.

FIG. 5A shows a perspective view of a strip of trays for pneumostomamanagement devices according to an embodiment of the present invention.

FIG. 5B shows a perspective view of an assembly of four strips of thetrays of FIG. 5B.

FIG. 5C shows the assembly of FIG. 5B with external packaging accordingto an embodiment of the present invention.

FIG. 6A shows a plan view of a support for holding multiple traysaccording to an embodiment of the present invention.

FIG. 6B shows a perspective view of the support of FIG. 6A as assembled.

FIG. 6C shows a perspective view of the support of FIGS. 6A and 6B asassembled with multiple trays.

FIG. 7 shows a perspective view of an alternative support for holdingmultiple trays according to an embodiment of the present invention.

FIG. 8A shows a perspective view of an alternative single tray supportaccording to an embodiment of the present invention.

FIG. 8B shows packaging for multiple trays utilizing the alternativesingle tray support of FIG. 8A.

DETAILED DESCRIPTION OF THE INVENTION

The following description is of the best modes presently contemplatedfor practicing various embodiments of the present invention. Thedescription is not to be taken in a limiting sense, but is made merelyfor the purpose of describing the general principles of the invention.It is to be understood that features described in reference to aparticular embodiments may be combined with features of other particularembodiments. The scope of the invention should be ascertained withreference to the claims. In the description of the invention thatfollows, like numerals or reference designators will be used to refer tolike parts or elements throughout. In addition, the first digit of areference number identifies the series of drawings in which thereference number first appears.

Pneumostoma Formation and Anatomy

FIG. 1A shows the chest of a patient indicating alternative locationsfor creating a pneumostoma that may be managed using the system andmethods of the present invention. A first pneumostoma 110 is shown onthe front of the chest 100 over the right lung 101 (shown in dashedlines). The pneumostoma is preferably positioned over the thirdintercostal space on the mid-clavicular line. Thus the pneumostoma 110is located on the front of the chest between the third and fourth ribs.Although the pneumostoma 110 is preferably located between two ribs, inalternative procedures a pneumostoma can also be prepared using aminithoracotomy with a rib resection.

In FIG. 1A, a second pneumostoma 112 is illustrated in a lateralposition entering the left lung 103 (shown in dashed lines). Thepneumostoma 112 is preferably positioned over the fourth or fifthintercostal space under the left arm 104. In general, one pneumostomaper lung is created; however, more or less than one pneumostoma per lungmay be created depending upon the needs of the patient. In most humans,the lobes of the lung are not completely separate and air may passbetween the lobes.

A pneumostoma is surgically created by forming an artificial channelthrough the chest wall and joining that channel with an opening throughthe visceral membrane of the lung into parenchymal tissue of the lung toform an anastomosis. The anastomosis is joined and sealed by sealing thechannel from the pleural cavity using adhesives, mechanical sealingand/or pleurodesis. Methods for forming the channel, opening,anastomosis and pleurodesis are disclosed in Applicant's pending andissued patents and applications including U.S. patent application Ser.No. 10/881,408 entitled “Methods and Devices to Accelerate Wound Healingin Thoracic Anastomosis Applications” and U.S. patent application Ser.No. 12/030,006 entitled “Variable Parietal/Visceral Pleural Coupling”which are incorporated herein by reference in their entirety.

FIG. 1B shows a sectional view of chest 100 illustrating the position ofthe pneumostoma 110. The parenchymal tissue 132 of the lung 130 iscomprised principally of alveoli 134. The alveoli 134 are the thinwalled air-filled sacs in which gas exchange takes place. Air flows intothe lungs through the natural airways including the trachea 136, carina137, and bronchi 138. Inside the lungs, the bronchi branch into amultiplicity of smaller vessels referred to as bronchioles (not shown).Typically, there are more than one million bronchioles in each lung.Each bronchiole connects a cluster of alveoli to the natural airways. Asillustrated in FIG. 1B, pneumostoma 110 comprises a channel through thethoracic wall 106 of the chest 100 between two ribs 107. Pneumostoma 110opens at an aperture 126 through the skin 114 of chest 100.

FIG. 1C shows a detailed sectional view of the pneumostoma 110. Asillustrated in FIG. 1C, pneumostoma 110 comprises a channel 120 throughthe thoracic wall 106 of the chest 100 between the ribs 107. The channel120 is joined to cavity 122 in the parenchymal tissue 132 of lung 130.Although shown having a particular shape, the channel 120 and cavity 122will typically conform to the shape of a device inserted into thepneumostoma 110. An adhesion or pleurodesis 124 surrounds the channel120 where it enters the lung 130. The thoracic wall 106 is lined withthe parietal membrane 108. The surface of the lung 130 is covered with acontinuous sac called the visceral membrane 138. The parietal membrane108 and visceral membrane 138 are often referred to collectively as thepleural membranes. Between the parietal membrane 108 and visceralmembrane 138 is the pleural cavity (pleural space) 140. The pleuralcavity usually only contains a thin film of fluid that serves as alubricant between the lungs and the chest wall. In pleurodesis 124 thepleural membranes are fused and/or adhered to one another eliminatingthe space between the pleural membranes in that region.

An important feature of the pneumostoma is the seal or adhesionsurrounding the channel 120 where it enters the lung 130 which maycomprise a pleurodesis 124. A pleurodesis 124 is the fusion or adhesionof the parietal membrane 108 and visceral membrane 138. A pleurodesismay be a complete pleurodesis in which the entire pleural cavity 140 isremoved by fusion of the visceral membrane 138 with the parietalmembrane 108 over the entire surface of the lung 130. However, as shownin FIG. 1C, the pleurodesis is preferably localized to the regionsurrounding the channel 120. The pleurodesis 124 surrounding the channel120 prevents air from entering the pleural cavity 140. If air ispermitted to enter pleural cavity 140, a pneumothorax will result andthe lung may collapse.

Pleurodesis 124 can be created between the visceral pleura of the lungand the inner wall of the thoracic cavity using chemical methodsincluding introducing into the pleural space irritants such asantibiotics (e.g. Doxycycline or Quinacrine), antibiotics (e.g.iodopovidone or silver nitrate), anticancer drugs (e.g. Bleomycin,Mitoxantrone or Cisplatin), cytokines (e.g. interferon alpha-2β andTransforming growth factor-β); pyrogens (e.g. Corynebacterium parvum,Staphylococcus aureus superantigen or OK432); connective tissue proteins(e.g. fibrin or collagen) and minerals (e.g. talc slurry). A pleurodesiscan also be created using surgical methods including pleurectomy. Forexample, the pleural space may be mechanically abraded duringthoracoscopy or thoracotomy. This procedure is called dry abrasionpleurodesis. A pleurodesis may also be created using radiotherapymethods, including radioactive gold or external radiation. These methodscause an inflammatory response and or fibrosis, healing, and fusion ofthe pleural membranes. Alternatively, a seal can be created in an acutemanner between the pleural membranes using biocompatible glues, meshesor mechanical means such as clamps, staples, clips and/or sutures. Theadhesive or mechanical seal may develop into pleurodesis over time. Arange of biocompatible glues are available that may be used on the lung,including light-activatable glues, fibrin glues, cyanoacrylates and twopart polymerizing glues. Applicant's copending U.S. patent applicationSer. No. 12/030,006 entitled “VARIABLE PARIETAL/VISCERAL PLEURALCOUPLING” discloses methods such as pleurodesis for coupling a channelthrough the chest wall to the inner volume of the lung without causing apneumothorax and is incorporated herein by reference for all purposes.

When formed, pneumostoma 110 provides an extra pathway for exhaled airto exit the lung 130 reducing residual volume and intra-thoracicpressure without the air passing through the major natural airways suchas the bronchi 138 and trachea 136. Collateral ventilation isparticularly prevalent in an emphysemous lung because of thedeterioration of lung tissue caused by COPD. Collateral ventilation isthe term given to leakage of air through the connective tissue betweenthe alveoli 134. Collateral ventilation may include leakage of airthrough pathways that include the interalveolar pores of Kohn,bronchiole-alveolar communications of Lambert, and interbronchiolarpathways of Martin. This air typically becomes trapped in the lung andcontributes to hyperinflation. In lungs that have been damaged by COPDand emphysema, the resistance to flow in collateral channels (not shown)of the parenchymal tissue 132 is reduced allowing collateral ventilationto increase. Air from alveoli 134 of parenchymal tissue 132 that passesinto collateral pathways of lung 130 is collected in cavity 122 ofpneumostoma 110. Pneumostoma 110 thus makes use of collateralventilation to collect air in cavity 122 and vent the air outside thebody via channel 120 reducing residual volume and intra-thoracicpressure and bypassing the natural airways which have been impaired byCOPD and emphysema.

By providing this ventilation bypass, the pneumostoma allows stale airtrapped in the parenchymal tissue 132 to escape from the lung 130. Thisreduces the residual volume and intra-thoracic pressure. The lowerintra-thoracic pressure reduces the dynamic collapse of airways duringexhalation. By allowing the airways to remain patent during exhalation,labored breathing (dyspnea) and residual volume (hyperinflation) areboth reduced. Pneumostoma 110 not only provides an extra pathway thatallows air to exit the lung 130 but also allows more fresh air to bedrawn in through the natural airways. This increases the effectivenessof all of the tissues of the lung 130 and improves gas exchange.Increasing the effectiveness of gas exchange allows for increasedabsorption of oxygen into the bloodstream and also increased removal ofcarbon dioxide. Reducing the amount of carbon dioxide retained in thelung reduces hypercapnia which also reduces dyspnea. Pneumostoma 110thus achieves many of the advantages sought by lung volume reductionsurgery without surgically removing a portion of the lung or sealing offa portion of the lung.

Applicants have found that pneumostoma management devices in accordancewith embodiments of the present invention are desirable to maintain thepatency of the pneumostoma and control flow of materials between theexterior of the patient and the parenchymal tissue of the lung via thepneumostoma. The pneumostoma management devices include a pneumostomavent to enter the pneumostoma and allow gases to exit the lung and mayalso include a chest mount, and/or one or more of the tools, packaging,auxiliary device and methods described herein. In general terms apneumostoma management device (“PMD”) or pneumostoma vent comprises atube which is inserted into the pneumostoma and an external componentwhich is secured to the skin of the patient to keep the tube in place.Gasses escape from the lung through the tube and are vented external tothe patient. The pneumostoma management device may, in some, but not allcases, include a filter which only permits gases to enter or exit thetube. The pneumostoma management device may, in some, but not all cases,include a one-way valve which allows gases to exit the lung but notenter the lung through the tube.

Pneumostoma Vent System

FIGS. 2A-2D show views of a pneumostoma management device 200.Pneumostoma management device 200. FIG. 2A shows an exploded view of thefour main components of pneumostoma management device 200. FIG. 2B showsa view of an assembled pneumostoma management device 200. FIG. 2C showsa perspective view of a component of the pneumostoma management device200. FIG. 2D shows a perspective view of the assembled pneumostomamanagement device 200. FIG. 2E shows a sectional view of the pneumostomamanagement device 200 positioned in a pneumostoma.

FIG. 2A shows an exploded view of the four main components ofpneumostoma management device. From right to left these components areannular adhesive cover 202, filter 204, pneumostoma vent 206 andhydrocolloid patch 208. Adhesive cover 202 is a thin porousbiocompatible membrane which is adhesive on the surface facing thepneumostoma (the inner surface see 222 in FIG. 2C) and non-adhesive onthe outer surface 220. A suitable material for adhesive cover 202 is aCHG Chlorhexidine Gluconate IV Securement Dressing available under theTradename TEGADERM™ from 3M of St. Paul, Minn. TEGADERM™ is thin layerof polyurethane bonded to a thin hydrocolloid adhesive layer. The filmis biocompatible as well as thin, strong, and breathable. Other thinbiocompatible dressings and adhesive films may be used as an alternativeto TEGADERM™. For example, a suitable material for adhesive cover 202 isa thin polyurethane film bearing an acrylic adhesive—such materials areavailable from 3M of St. Paul, Minn. The film is biocompatible as wellas thin, strong, and breathable. Adhesive cover 202 has an aperture 224large enough to allow air to exit through filter 204. Aperture 224 mayhowever be slightly smaller than filter 204 so that the cover can beused to secure filter 204 to pneumostoma vent 206. Exposed portions ofadhesive cover 202 are provided with a paper cover to protect theadhesive ring prior to use (see FIGS. 3A-3 f).

As shown in FIG. 2A, a filter 204 is positioned between adhesive cover202 and pneumostoma vent 206. Filter 204 is a circular disc of filtermaterial. Filter 204 is preferably a hydrophobic filter material, forexample GORETEX®. Filter 204 is in some embodiments made fromreticulated open cell polyurethane foam or an open cell polyurethane orpolyester foam or melt blown polyethylene. Exemplary filter materialsinclude DELPORE® DP2001-10P, DELPORE® DP2001-20P, and DELPORE®DP2001-30P available from Delstar Technologies, Inc. (Middletown, Del.).Filter 204 is larger than the proximal aperture in pneumostoma vent 206and is positioned over the proximal aperture. Filter 204 may be securedto pneumostoma vent 206 by and adhesive, welding, or other bondingtechnology. In a preferred embodiment, filter 204 is secured to ventflange 262 with a ring of pressure sensitive adhesive. Filter 204 mayalso be secured to pneumostoma vent 206 by annular adhesive cover 202instead of or in addition to other bonding techniques. Filter 204 allowsgasses to exit the lung through pneumostoma vent 206 while preventingthe entry of water and/or contaminants into the lung through thepneumostoma vent. Additionally, filter 204 traps within the pneumostomavent 206 any liquid or solid discharge from the lung.

As shown in FIGS. 2A and 2C, pneumostoma vent 206 comprises a tube 260for entering the pneumostoma. Tube 260 has an atraumatic tip 265 and oneor more apertures 267 in the distal end to allow gases and discharge toenter tube 260 from the pneumostoma. Tube 260 is connected to a flange262 at the proximal end. Flange 262 may be formed in one piece with tube260 or formed separately and joined to tube 260 as previously describedwith respect to other embodiments. The proximal opening 263 ofpneumostoma vent 206 is sized so that filter 204 covers proximal opening263. Vent 206 may be made of a suitable plastic/thermoplasticpolymer/thermoplastic elastomer. For example in one preferred embodimentvent 206 is made of Pebax® a block copolymer with suitable mechanicaland chemical properties available from Arkema (Colombes, France).

Referring again to FIG. 2A, hydrocolloid patch 208 has an aperture 209through which tube 260 can be placed but too small to allow passage offlange 262. Hydrocolloid patch 208 is a biocompatible hydrocolloidmaterial which is naturally sticky like an adhesive on both sides. Thehydrocolloid material may be provided with a film coating and atransitional adhesive on the side facing flange 262 and cover 202 inorder to better secure hydrocolloid patch 208 to the flange and annularcover. Hydrocolloid patch 208 is preferably less than 3 mm thick and ismore preferably, approximately 1 mm in thickness. However, thehydrocolloid patch may be thicker if absorbing requirements of thedischarge around the tube is high. Additionally a thicker ring ofhydrocolloid may provide a forgiving surface to secure pneumostomamanagement device 200 to a rough or highly contoured skin surface.Hydrocolloid patch 208 is in some embodiments substantially transparent.Exposed portions of hydrocolloid patch 208 are provided with a papercover (not shown) to protect the exposed areas of the hydrocolloid patchprior to use.

Referring now to FIG. 2B which shows a plan view of an assembly of allfour main components including adhesive cover 202, filter 204,pneumostoma vent 206 and hydrocolloid patch 208. Pneumostoma managementdevice 200 may be provided as a kit of separate components or one ormore of the components may be preassembled when provided to the patient.As shown in FIG. 2B, tube 260 fits through the middle of hydrocolloidpatch 208. Note also that flange 262 is trapped between annular adhesivecover 202 and filter 204/hydrocolloid patch 208. In this embodiment,filter 204 is also secured to pneumostoma vent 206 by adhesive cover202. Exposed adhesive regions of annular adhesive ring 202 andhydrocolloid patch 208 on the patient side of the pneumostoma managementdevice 200 are provided with protective covers (for example papercovers) to protect the exposed adhesive areas during shipping and priorto use. The completed or partially completed assembly is provided as asterile product to the patient or caregiver who inserts the tube 260 ofpneumostoma vent 206 into a pneumostoma and secures the hydrocolloidpatch 208 and adhesive cover to the skin of the chest surrounding thepneumo stoma.

Referring now to FIG. 2D which shows a perspective view of assembledpneumostoma management device 200. The outer edges of filter 204 andhydrocolloid patch 208 are shown by dotted lines. As shown in FIG. 2D,adhesive cover 202 secures filter 204 over pneumostoma vent 206. Tube260 of pneumostoma vent 206 is aligned with filter 204 such that gasescan pass through tube 260 and filter 204.

FIG. 2E shows a sectional view of pneumostoma management device 200 inposition within a pneumostoma 110. As shown in FIG. 2E, tube 260 isinserted into the pneumostoma 110 and passes through the wall of chest100 and into the lung 130. Aperture 267 in the distal end of tube 260 ispositioned inside the lung 130 so that gases and discharge may enter thetube 260 of the pneumostoma management device 200. Flange 262 ofpneumostoma vent 206 is secured to the skin 114 of the patient byhydrocolloid patch 208 and adhesive cover 202. Flange 262 secures theposition of tube 260 within pneumostoma 110. Flange 262 secures theposition of aperture 263 on the chest of the patient such that gasesfrom the lung may vent through tube 260 and filter 204. Bothhydrocolloid patch 208 and adhesive cover 202 contact the skin 114 ofthe patient to secure the pneumostoma management device 200 to the chest100 of the patient. In some cases a barrier film may be applied by thepatient prior to securing the pneumostoma management device to reduceskin irritation caused by application and removal of the system. Anadditional ring of absorbent material (not shown), for example, gauze oranother absorbent fabric may be positioned around tube 260 betweenhydrocolloid patch 208 and the skin 114 of the patient for absorbing anydischarge from pneumostoma 110 which escapes around tube 260.

Referring again to FIG. 2E, during use, the distal end 265 ofpneumostoma vent 206 is placed into the pneumostoma 110 and tube 260 ispushed gently and slowly into the pneumostoma 110. The pneumostoma tube260 aligns itself with the pneumostoma 110 such that when thehydrocolloid patch 208 and adhesive cover 202 contacts and adheres tothe skin 114 of the chest 100, the aperture 224 is perfectly alignedwith the pneumostoma 110. Gasses may then escape from the lung into thepneumostoma 110. Gasses in pneumostoma 110 enter tube 260 and passthrough filter 204 and vent to atmosphere as shown by arrow 220.

Protective Covers

One aspect of a pneumostoma management system includes protective coverswhich protect the adhesive portions of the pneumostoma management deviceprior to use. These protective covers serve the same purpose as thepaper covers on an adhesive bandage. However, in preferred embodimentsof the present invention, the protective covers are specially designedto facilitate application of the pneumostoma management device. In apreferred embodiment, the protective covers are made from a thindisposable material which can be readily released from the adhesivesurfaces. A suitable material is paper waxed on one surface.

FIGS. 3A-3E shows aspects of a set of protective covers 300 suitable forapplication to pneumostoma management device 200. FIG. 3A shows all ofthe components of protective cover set 300 which includes inner covers310 a, 310 b outer covers 320 a 320 b, tab covers 330 a, 330 b. Innercovers 310 a, 310 b are designed to protect the exposed adhesive surfaceof hydrocolloid patch 208. Outer covers 320 a, 320 b are designed toprotect the exposed adhesive surface of adhesive cover 202 withoutobstructing the removal of inner covers 310 a, 310 b. Tab covers 330 a,330 b are designed to protect the outer edges of adhesive cover 202 sothat a patient can more easily handle the adhesive cover 202 afterremoval of inner covers 210 a, 210 b and outer covers 220 a, 220 b.

FIGS. 3B-3D illustrate an inner cover 310 b. Inner cover 310 a (notshown) is identical to cover 310 b. As shown in FIG. 3B, inner cover 310b is substantially congruent in shape with hydrocolloid patch 208. Innercover 310 b has an aperture 312 b, sized to fit the outer diameter oftube 260. Inner cover 310 b also has a full side 314 b and a truncatedside 315 b. Prior to use inner cover 310 b is folded along dotted line316 b. This results in the configuration shown in FIG. 3C in whichaperture 312 b forms a half circle and truncated side 315 b ispositioned over full side 314 b. As shown in FIG. 3D full sides 314 a,314 b of inner covers 310 a, 310 b are placed in contact with theexposed adhesive surface of hydrocolloid patch 208 (obscured). Truncatedsides 315 a, 315 b are slightly elevated on either side of pneumostomavent 260 providing a handle for easy removal of inner covers 310 a, 310b. During application, inner covers 310 a, 310 b are removed first.Inner covers 310 a, 310 b are removed by gripping and pulling truncatedsides 315 a, 315 b to expose hydrocolloid patch 208 (obscured). Whenhydrocolloid patch 208 is exposed tube 260 is inserted into thepneumostoma and hydrocolloid patch 208 adheres to the skin of the chest.The presence of outer covers 320 a, 320 b and tab covers 330 a, 330 bduring insertion of the tube allows the patient to manipulate the tubewithout touching the tube. Thus the sterility of the tube can bepreserved when entering the pneumostoma.

FIG. 3D illustrates the application of tab covers 330 a, 330 b to theouter edges of adhesive cover 202. As shown in FIG. 3D, tab covers 330a, 330 b protect the outer edges of adhesive cover 202 so that a patientcan more easily handle the adhesive cover 202 after removal of innercovers 210 a, 210 b (not shown) and outer covers 220 a, 220 b (notshown). Outer covers 220 a, 220 b are removed subsequent to removal ofadhesion of hydrocolloid patch 208 to the skin of the patient. Tabcovers 330 a, 330 b allow the patient to handle the outer edges ofadhesive cover 202 while the patient pushes the remainder of adhesivecover 202 into contact with skin of the chest. After the major portionof adhesive cover 202 has been secured to the chest, tab covers 330 a,330 b are removed. In alternative embodiments, tab covers arepermanently affixed to the outer edges of adhesive cover 202 in order tofacilitate both placement and removal of pneumostoma management device200.

FIG. 3E shows set of protective covers 300 as assembled with pneumostomamanagement device 200 (partially obscured). As shown in FIG. 3E, outercovers 320 a, 320 b include inner channels 322 a, 322 b designed toaccommodate the removal of inner covers 310 a, 310 b. Pneumostoma vent206 protrudes from pneumostoma management device 200 through the set ofprotective covers 300.

FIG. 3F shows an alternative embodiment of a set of protective covers300 f protective which includes, a tube cover 340 in addition to innercovers 310 a, 310 b outer covers 320 a 320 b, tab covers 330 a, 330 b.As shown in FIG. 3F, tube cover 340 comprises a long rectangular strip342 of material (for example paper). The strip 342 is folded in half andsides 343, 344 adhered to themselves along part of their length to forma pocket 341, ends 345, 346 can be folder back or adhered to innercovers 310 a, 310 b so that tube cover 340 can be removed at the sametime as inner covers 310 a, 310 b. In alternative embodiments a tubecover 340 is made in a different configuration or material than show. Insome embodiments, the use of a tube cover in combination with covers forprotecting the exposed adhesive portion of the pneumostoma vent issufficient to preserve the sterility of the pneumostoma managementdevice.

After creating and healing of the pneumostoma the patient will beresponsible for applying and removing the pneumostoma management device200. The patient will typically exchange one pneumostoma managementdevice 200 for another and dispose of the used pneumostoma managementdevice 200. Pneumostoma management device 200 will be replacedperiodically, such as daily, or when necessary. The patient will beprovided with a supply of pneumostoma management devices 200 by amedical practitioner or by prescription. The pneumostoma managementdevices are preferably provide to the patient in the form of apneumostoma management system which includes packaging, instructionsand/or auxiliary supplies to facilitate delivery, sterility, disposaland/or proper use of the pneumostoma management device 200.

Pneumostoma Management Systems

In preferred embodiments of the present invention a pneumostomamanagement system includes one or more pneumostoma management devicesand also one or more of sterile packaging, kit packaging, auxiliarysupplies and instructions for use. In preferred embodiments thepneumostoma management system, includes packaging and instructions whichassist the patient in utilizing the components of the system in thecorrect sequence. The packaging may include printed instructions whichassist the patient in the appropriate sequence of the steps for usingthe pneumostoma management device. In addition, the packaging caninclude auxiliary supplies, for example, cleaning and moisturizing swabsand barrier spray/cream. The packaging of the pneumostoma managementsystem may also be designed to provide the components to the patient inthe order required for use and to maintain sterility during use. Forexample, the package may be designed so that, upon opening the package,items are physically arranged in a tray in the order in which they areto be used by the patient.

In preferred embodiments, the packaging is designed to providepneumostoma management devices and auxiliary materials sufficient tomaintain a pneumostoma for multiple days in a volume-efficient package.For example, in preferred embodiments, the packaging is designed toprovide pneumostoma management devices and auxiliary materialssufficient to maintain a pneumostoma for one week, two weeks, four weeksor one month.

Sterile Tray

As described above, a pneumostoma management system incorporates in someembodiments a sterile tray which holds the pneumostoma management deviceprior to use. FIGS. 4A-4B show exploded and assembled views of apneumostoma management system 400 including a pneumostoma managementdevice 200, a set of protective covers 300, a sterile tray 410 andsterile tray cover 430.

As shown in FIG. 4A, pneumostoma management system 400 includes a tray410. In a preferred embodiment tray 410 is a vacuum-formed orinjection-molded thermoplastic tray. Tray 410 includes a tray base 415with a planar raised edge 412 and a shallow depression 414, and atubular extension 416 extending in this preferred embodiment aboutperpendicular to the tray base 415. Shallow depression 414 is sized toreceive the exterior portions of pneumostoma management device 200 andcover 300. For example, shallow depression 414 is in some embodimentsapproximately 110 mm by 100 mm by 5 mm deep. Tubular extension 416extends from the middle of shallow depression 414 and is sized toreceive the tube 260 of pneumostoma management device 200.

Tray cover 430 is a thin flexible covering which protects thepneumostoma management device and keeps bacteria out of tray 410. Traycover 430 is adapted to be removably secured top tray 410. Tray cover430 can be provided with one or more tabs 432 which can be gripped topeel tray cover 430 away from tray 410. The tray cover material is insome embodiments, selected to allow sterilization of the pneumostomamanagement device 200 inside pneumostoma management system 400 afterattachment of cover 430. For example, tray cover is, in someembodiments, selected to be permeable to ethylene oxide such thatpneumostoma management system 400 can be sterilized after assembly. Insome embodiments tray cover 430 is made of TYVEK® available from DuPont.

During assembly, tube 260 of pneumostoma management device 200 isinserted into tubular extension 416. The external portion of pneumostomamanagement device 200 is placed in shallow depression 414, and traycover 430 is secured to raised rim 412. In a preferred embodiment apressure sensitive and/or contact adhesive is used to secure tray cover430 to raised rim 412. After assembly pneumostoma management system 400is exposed to ethylene oxide gas for a preselected period of time. Theethylene oxide penetrates through tray cover 430 and sterilizes thesurfaces of tray 410 and also sterilizes the pneumostoma managementdevice 200 and set of covers 300. Thus, the pneumostoma managementsystem provides the pneumostoma management device 200 sterile and readyfor use by the patient.

To simplify manufacturing, a single tray configuration is designed tocontain a range of different pneumostoma management devices. Forexample, tubular extension 416 is, in some embodiments, approximately 95mm deep and 10 mm in inside diameter. Thus, for example, althoughpneumostoma management devices are made in various sizes having tubes260 of sizes between 35 mm and 95 mm, a single tray having a tubularextension 95 mm deep can accommodate any of the range of pneumostomamanagement devices.

FIG. 4B shows a view of pneumostoma management system 400 after assemblyand sterilization. Tray cover 430 is secured to tray 410 to protect thepneumostoma management device within tray 410 and maintain sterilityduring transit. An informational label 440 is adhered and/or printed ontray cover 430. The informational label includes printed information 442such as size, source origin, batch number and/or other FDA mandatedinformation to identify the pneumostoma management device containedwithin. The printed label 440 can also include instructions for use. Theprinted information 442 can be provided alphanumerically and/or withpictograms/symbols.

The tray configuration of FIGS. 4A and 4B is well-suited to protect andmaintain the sterility of a pneumostoma management device. However, thetray configuration is not readily packed in a compact size. For example,taking the maximum size of each direction, the single tray configurationoccupies a ‘cube’ of 110 mm×100 mm×100 mm. The packaging volume of this‘cube’ is greater than a liter. In preferred embodiments, where apatient exchanges the pneumostoma management device daily, a month'ssupply of pneumostoma management devices could occupy a total packagingvolume of some 30 liters. This is inconvenient for the patient to carryand store. The difficulty is magnified at the distributor/pharmacy levelwhere pneumostoma management devices must be maintained in multiplesizes for different patients. It would also increase shipping/deliverycharges associated with the device. Thus, it is preferred to reduce theeffective packaging volume utilizing volume-efficient packaging formultiple trays as described below.

Multi-Tray Strips

To facilitate delivery, pneumostoma management system 400 is, in someembodiments, provided as a part of a multi-tray strip. For example, amulti-tray strip can include two, three, four or more pneumostomamanagement devices in sterile trays which are releasably or permanentlyattached to one another. In a preferred embodiment a multi-tray stripcan include seven pneumostoma management devices in sterile trays. Eachtray preferably is provided with an independent tray cover such that onepneumostoma management device can be removed at a time while preservingthe sterility of the remaining pneumostoma management devices.

The trays are, in some embodiments, identical but in other embodiments,include different items. For example, one or more of the pneumostomamanagement devices can include different components and/or attributessuitable for treating or assessing the pneumostoma on a periodic basis.In some embodiments, for example, one pneumostoma management devices perstrip of seven includes means for assessing pneumostoma. Thus, a patientwill perform a weekly assessment of pneumostoma health and/orfunctionality, the results of which the patient can report to aphysician in order that the physician can make recommendations regardingfurther diagnosis and/or treatment of the pneumostoma.

FIG. 5A shows an example of a multi-day strip 510 including sevenpneumostoma management systems 400 having interconnected trays 410. Thetrays 410 are, in some embodiments, formed in one piece. For example themulti-day strip 510 can be vacuum formed in one piece. The tray can beperforated along a line between adjoining trays to allow separation ofadjoining trays. Alternatively, the trays 410 are releasably attached toone another before or after sterilization. For example, adjoining trayscan be secured to one another using a releasable tape. Note however,that each tray 410 has a tray cover 430 that can be removedindependently of the remaining tray covers 430.

FIG. 5B shows a suitable configuration for packaging together includingfour multi-day strips 510. As shown in FIG. 5B, the four pneumostomamulti-day strips 510 are arranged in the shape of a rectangular cuboidwith the tubular extensions 416 of the trays arranged in the innervolume of the rectangular cuboid. Each of the four multi-day strips islinearly displaced from neighboring strips by at least the width of thetubular extensions 416 so that tubular extensions 416 do not interferewith one another.

FIG. 5C shows a kit 500 which includes four multi-day strips 510arranged in the configuration of FIG. 5B and packaged in externalpackaging 520. External packaging 520 is a medical-grade card box. Inthis configuration, 28 pneumostoma management systems 400 can besupplied in a total package volume of approximately 8 liters or 0.29liters per unit. This is a considerable savings in packaging volumecompared to individual packaging. Kit 500 is a manageable size fordelivery to a patient and transportation by a patient and supplies apatient with the ability to maintain a pneumostoma for four weekswithout returning to the pharmacy.

External packaging 520 can be provided with an external label 522indicating the contents batch number and/or information required by theFDA and or a pharmacy. External label 522 is, in some embodiments,provided on the end 524 of external packaging 520, as shown.End-labeling the packages means that the packages can be stackedefficiently on pharmacy shelves while permitting easy location of apackage suitable for a particular patient. The end 524 of externalpackaging 520 is smaller in area than the sides of external packaging520, thus allowing a greater number of labels to be exposed in a stackof packaging.

Tray Support

FIGS. 6A-6C illustrate an alternative packaging system for supporting aplurality of pneumostoma management systems 400. FIG. 6A shows a planview of a support 610. FIG. 6B shows a perspective view of support 610,as assembled. FIG. 6C shows a kit 600 including 10 pneumostomamanagement systems 400 and packaging system 600.

FIG. 6A shows a plan view of a support 610. As shown in FIG. 6A, support610 is, in some embodiments, created from a single sheet 612 of medicalgrade card. The pattern shown in FIG. 6A is preferably stamped in one gofrom card stock. As shown in FIG. 6A, the pattern delineates four sidepanels 612 a, 612 b, 612 c, 612 d; two end panels 614 a, 614 b; and fiveflaps 616 a, 616 b, 616 c, 616 d, 616 e. To facilitate folding andassembly, the card is, in some embodiments, scored along the dashedlines illustrated.

A plurality of holes 620 are punched in the side panels 612 a, 612 b,612 c, 612 d. Each hole 620 comprises a central aperture 622 and aplurality of radiating slots 624. The holes 620 are sized slightlysmaller than the tubular extension 416 of the sterile pneumostomamanagement system 400. The slots 624 allow the card surrounding theaperture 622 to bend and conform to the tubular extension 416 of thesterile pneumostoma management system 400.

A plurality of slots 630 are punched in the side panels 612 a, 612 b,612 c, 612 d and end panels 614 a, 614 b. Each slot 630 defines a tab632. The tabs 632 are designed to space support 610 from externalpackaging as illustrated in FIGS. 6B, 6C.

During assembly, an adhesive (not shown) is applied to the surface offlap 616 a which is then bonded to side panel 612 d to create asubstantially square-sectioned tube having an interior volume. Flaps 616b, 616 c, 616 d, 616 e are then folded over the ends of thesquare-sectioned tube. Finally, end panels 614 a, 614 b are folded overflaps 616 b, 616 c, 616 d, 616 e. Ends 615 a, 615 b are inserted intothe interior volume to secure end panels 614 a, 614 b in place.

FIG. 6B shows a perspective view of support 610, as assembled. As shownin FIG. 6B, side panels 612 a, 612 b, 612 c, 612 d and end panels 614 a,614 b form the surfaces of a rectangular cuboid enclosing an interiorvolume. Four tabs 632 project adjacent each of end panels 614 a, 614 bto serve as spacers. Ten apertures 620 pass through side panels 612 a,612 b, 612 c, 612 d into the interior volume of the rectangular cuboid.

FIG. 6C shows a kit 600 which includes a plurality of pneumostomamanagement systems 400 assembled with support 610 and external packaging640. As shown in FIG. 6C, the tubular extension of each tray 410 isplaced through a hole 620 into the interior volume of the support 610.As most clearly shown in FIG. 6A, the holes are arranged such that thetubular extensions 416 are displaced from one another in the interior ofsupport 610. The trays 410 are pushed against the side panels 612 a, 612b, 612 c, 612 d. The trays 410 can overlap one another as shown. Thetabs 632 project slightly beyond the trays 410. A total of tenpneumostoma management systems 400 can be assembled on support 610. Thecombination of support 610 and pneumostoma management system 400 is theninserted into external packaging 640 in the form of a box made ofmedical grade cardboard. Tabs 632 serve to space support 610 from thesides of external packaging 640 to allow room for trays 410.

Kit 600 provides pneumostoma management supplies sufficient for ten daysof at-home pneumostoma care in volume-efficient packaging. With thisconfiguration, for example, ten pneumostoma management devices 400 aresupplied in a total package volume of approximately 6 liters or 0.6liters per unit. This is a considerable savings in packaging volumecompared to single trays.

FIG. 7 illustrates an alternative kit 700 which includes a support 710and a plurality of pneumostoma management systems 400. As shown in FIG.7, kit 700 can include up to 32 pneumostoma management systems 400packaged with a support 710 and external packaging 780. Support 710 is,in some embodiments, created from a single block 712 of a lightweightmaterial such as a foam or expanded plastic. A grid of apertures 720 isformed into opposite sides of the block 712. The apertures 720 areoffset from one another so that the apertures on opposite sides ofsupport 710 do not interfere with one another. The size of the block 712and the number of apertures 720 is selected to allow support 710 toreceive a desired number of sterile trays 410. Kit 700 can beconfigured, for example, to support 7, 14, 28 or more pneumostomamanagement systems

The tubular extension of each tray 400 of pneumostoma management systems400 is placed through an aperture 720 into the interior volume of thesupport 710. A total of 16 pneumostoma management systems 400 can bereceived into the apertures 420 on each side of support 710. Theassembly of pneumostoma management devices 400 and support 710 isdesigned to be placed inside external packaging 780. External packaging780 is a box made of medical-grade card and only slightly larger ininternal dimensions that the maximum external dimensions of the assemblyof pneumostoma management devices 400 and support 710. In theconfiguration of FIG. 7, for example, pneumostoma management devices 400can be supplied in a total package volume of approximately 16 liters or0.5 liters per unit. This is a considerable savings in packaging volumecompared to single trays. Additional volume savings can be achieved byoverlapping the trays somewhat.

FIGS. 8A-8B shows an alternative support 810. Support 810 is designed tosupport a single pneumostoma management system 400. Support 810 is inthe form of a wedge 812 with each wedge including an aperture 820. Wedge812, can be made out of a lightweight material such as a foam orexpanded plastic. Aperture 820 is connected to one side of wedge 812 bya slot 814. The tubular extension 416 of a pneumostoma management system400 is placed through aperture 820 into the interior volume of wedge812. Alternatively, the tubular extension 416 of a pneumostomamanagement system 400 is placed through slot 814 into the interiorvolume of wedge 812.

As shown in FIG. 8B, wedge 812 is designed so that a plurality of wedges812 can be stacked to form a rectangular cuboid configuration with aplurality of pneumostoma management systems 400 entering from opposingsides. The configuration avoids interference of the tubular extensionsof the pneumostoma management systems. As shown in FIG. 8B, fourteenpneumostoma management systems are provided as part of kit 800 which canbe placed in external packaging box 880. The plurality of foam supports810 and pneumostoma management systems 400 may then be inserted intoexternal packaging 880. Again, with this configuration, for example,fourteen pneumostoma management devices 400 can be supplied in a totalpackage volume of approximately 7 liters or 0.5 liters per unit. This isa considerable savings in packaging volume compared to single trays.Additional volume savings can be achieved by overlapping the trayssomewhat.

Materials

In preferred embodiments the pneumostoma management device and tray areformed from biocompatible polymers. In general, preferred materials formanufacturing pneumostoma management devices and trays are biocompatiblethermoplastic elastomers that are readily utilized in injection moldingand extrusion processing. As will be appreciated, other suitablesimilarly biocompatible thermoplastic or thermoplastic polymer materialscan be used without departing from the scope of the invention.

Biocompatible polymers for manufacturing pneumostoma management devicesand trays may be selected from the group consisting of polyethylenes(HDPE), polyvinyl chloride, polyacrylates (polyethyl acrylate andpolymethyl acrylate, polymethyl methacrylate, polymethyl-coethylacrylate, ethylene/ethyl acrylate), polycarbonate urethane (BIONATEG),polysiloxanes (silicones), polytetrafluoroethylene (PTFE, GORE-TEX®,ethylene/chlorotrifluoroethylene copolymer, aliphatic polyesters,ethylene/tetrafluoroethylene copolymer), polyketones(polyaryletheretherketone, polyetheretherketone,polyetherether-ketoneketone, polyetherketoneetherketoneketonepolyetherketone), polyether block amides (PEBAX, PEBA), polyamides(polyamideimide, PA-11, PA-12, PA-46, PA-66), polyetherimide, polyethersulfone, poly(iso)butylene, polyvinyl chloride, polyvinyl fluoride,polyvinyl alcohol, polyurethane, polybutylene terephthalate,polyphosphazenes, nylon, polypropylene, polybutester, nylon andpolyester, polymer foams (from carbonates, styrene, for example) as wellas the copolymers and blends of the classes listed and/or the class ofthermoplastics and elastomers/thermoplastic elastomers in general. Inone preferred embodiment, the tube is made of Pebax® a block copolymerwith suitable mechanical and chemical properties available from Arkema(Colombes, France). Another suitable material is C-FLEX® thermoplasticelastomer available as extruded tube in a variety of dimensions anddurometers from Saint-Gobain Performance Plastics in Clearwater, Fla.Reference to appropriate polymers that can be used for manufacturingpneumostoma management devices and trays can be found, for example, inthe following documents: PCT Publication WO 02/02158, entitled“Bio-Compatible Polymeric Materials;” PCT Publication WO 02/00275,entitled “Bio-Compatible Polymeric Materials;” and, PCT Publication WO02/00270, entitled “Bio-Compatible Polymeric Materials” all of which areincorporated herein by reference.

The foregoing description of preferred embodiments of the presentinvention has been provided for the purposes of illustration anddescription. It is not intended to be exhaustive or to limit theinvention to the precise forms disclosed. Many embodiments were chosenand described in order to best explain the principles of the inventionand its practical application, thereby enabling others skilled in theart to understand the invention for various embodiments and with variousmodifications that are suited to the particular use contemplated. It isintended that the scope of the invention be defined by the claims andtheir equivalents.

1. A packaging system adapted for storing multiple medical disposabledevices in a volumetric efficient manner comprising: a plurality oftrays connected together with each tray including a tray base withtubular extension extending about perpendicular and rearwardly from thetray base; a tray cover that covers each of the plurality of trays; asecond plurality of trays each with second tubular extensions; and withthe plurality of trays positioned about parallel to the second pluralityof trays; and wherein said plurality of trays, and said second pluralityof trays, are all connected together by at least one of an internalstructure, a solid internal structure, a hollow structure, a lightweight material including at least one of foam and an expanded plastic,a structure with a plurality of ports that receive said tubularextensions, and a housing that contains a plurality of wedge shapedstructure that can receive said tubular extensions.
 2. The system ofclaim 1 wherein said plurality of trays is connected in-line.
 3. Apackaging system adapted to store multiple medical disposable devices ina volumetric efficient manner comprising: a plurality of planar coversconnected together, with each planar cover including a tubular coverextending about perpendicular and rearwardly from each of the planarcover; a second plurality of planar covers, each with a second tubularcover extending from each said tubular cover; and with the plurality ofplanar covers is about parallel to the second plurality of planarcovers; and wherein said plurality of planar covers, and said secondplurality of planar covers, are all connected together by at least oneof an internal structure, a solid internal structure, a hollowstructure, a light weight material including at least one of foam and anexpanded plastic, a structure with a plurality of ports that receivesaid tubular covers, and a housing that contains a plurality of wedgeshaped structure that can receive said tubular covers.
 4. A medicaldevice with a protective cover system comprising: a cover, at least partof which includes an adhesive, and a vent extending about perpendicularto the cover; a first protective cover covering a first portion of thecover and at least partially encircling said vent; a second protectivecover covering a second portion of the cover and at least partiallyencircling said vent; and a vent cover covering said vent and said ventcover connected to at least one of said first protective cover and saidsecond protective cover, such that when at least on of said firstprotective cover and second protective cover is removed, said vent isexposed.
 5. The system of claim 4 wherein removing at least one of saidfirst protective cover and said second protective cover, removes saidvent cover.
 6. The system of claim 4 including: a hydrocolloid patch atleast partially encircling said vent and positioned adjacent to saidcover so as to least part of said adhesive from said cover is exposed;said first protective cover and said second protective cover coveringsaid hydrocolloid patch; and a first outer protective cover positionedoutwardly from said first protective cover and covering the adhesive ofsaid cover, and a second outer protective cover positioned outwardly ofsaid second protective cover and covering the adhesive of said cover. 7.The system of claim 4 including at least one tab protective cover thatcovers at least a portion of said cover on a side of said cover that isopposite the adhesive.
 8. The system of claim 4 including a first tabprotective cover that covers at least a portion of said cover on a sideof said cover that is opposite the adhesive and a second tab protectivecover that covers at least a portion of said cover on a side of saidcover that is opposite to the adhesive, and wherein said first tabprotective cover is opposite said second tab protective cover.
 9. Thesystem of claim 4 wherein said vent cover includes a first vent coverand a second vent cover, with the first vent cover connected to saidfirst protective cover, and said second vent cover connected to saidsecond protective cover.
 10. The system of claim 4 wherein said firstprotective cover includes a first tab located adjacent to said vent forremoving said first protective cover and said second protective coverincludes a second tab located adjacent to said vent for removing saidsecond protective cover.
 11. The system of claim 4 wherein: said ventcover includes a first vent cover and a second vent cover, with thefirst vent cover connected to said first protective cover, and saidsecond vent cover connected to said second protective cover and saidfirst protective cover includes a first tab located adjacent to saidvent for removing said first protective cover and said first vent cover,and said second protective cover includes a second tab located adjacentto said vent for removing said second protective cover and said secondvent cover.
 12. The system of claim 9 including a hydrocolloid patch atleast partially encircling said vent and positioned adjacent to saidcover so as to least part of said adhesive from said cover is exposed;said first protective cover and said second protective cover coveringsaid hydrocolloid patch; and a first outer protective cover positionedoutwardly from said first protective cover and covering the adhesive ofsaid cover, and a second outer protective cover positioned outwardly ofsaid second protective cover and covering the adhesive of said cover.13. The system of claim 10 including a hydrocolloid patch at leastpartially encircling said vent and positioned adjacent to said cover soas to least part of said adhesive from said cover is exposed; said firstprotective cover and said second protective cover covering saidhydrocolloid patch; and a first outer protective cover positionedoutwardly from said first protective cover and covering the adhesive ofsaid cover, and a second outer protective cover positioned outwardly ofsaid second protective cover and covering the adhesive of said cover.14. The system of claim 11 including a hydrocolloid patch at leastpartially encircling said vent and positioned adjacent to said cover soas to least part of said adhesive from said cover is exposed; said firstprotective cover and said second protective cover covering saidhydrocolloid patch; and a first outer protective cover positionedoutwardly from said first protective cover and covering the adhesive ofsaid cover, and a second outer protective cover positioned outwardly ofsaid second protective cover and covering the adhesive of said cover.15. The system of claim 10 wherein said first tab is bent back over atleast part of said first protective cover, and said second tab is bentback over at least part of said second protective cover.
 16. The systemof claim 11 wherein said first tab is bent back over at least part ofsaid first protective cover, and said second tab is bent back over atleast part of said second protective cover.
 17. The system of claim 6wherein said first outer cover extends beyond said cover and said secondouter cover extends beyond said cover.
 18. The system of claim 3 incombination with multiple medical disposable devices wherein eachdisposable devices includes an adhesive cover and a vent extending aboutperpendicular from said adhesive cover.